MAUDE Adverse Event Report: COOK INC TURBO-JECT® SINGLE LUMEN BEDSIDE POWER-INJECTABLE PICC; LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

Model Number	G34517
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported an anesthetist opened a turbo-ject® single lumen bedside power-injectable picc during pre-op and discovered two small pieces of rubber in the package.A new kit was opened and used to complete the scheduled procedure.As reported, this foreign matter was discovered prior to use.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, and quality control, of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, an image of one of the pieces of foreign matter in the package was provided along with the complaint notification.This image confirms the presence of foreign matter within the package.Also, a document based investigation evaluation was performed.A review of the device history record shows one related non-conformance was found.One device was reworked back into the lot after foreign matter was discovered loose with in the tray.A review of the complaint database found there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, the root cause is manufacturing related, as the device was delivered to the customer with foreign matter embedded within the package.Although there was a related non-conformance associated with the product lot, no additional complaints have been reported for the lot and no related lots packaged that day have any related non-conformances or complaints associated with these lots.Based on this information, there is no evidence to suggest there are additional non-conforming products in house or in field.We will notify appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: TURBO-JECT® SINGLE LUMEN BEDSIDE POWER-INJECTABLE PICC
• Common Device Name: LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7489805
• Report Number: 1820334-2018-01329
• Device Sequence Number: 1313836
• Product Code: LJS
• UDI-Device Identifier: 00827002345171
• UDI-Public: (01)00827002345171(17)200109(10)8499600
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K132334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G34517
• Device Catalogue Number: UPICS-4.0-CT-40NT-1111
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1